Treatment of amyloidogenic diseases
First Claim
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1. A method of therapeutically treating Alzheimer'"'"'s disease, comprising administering by intravenous infusion to a human patient suffering from the disease a dosage of an antibody that specifically binds to an N-terminal fragment of beta-amyloid peptide (Aβ
- ) with a binding affinity of at least 107 M−
1, and monitoring the patient for posterior reversible encephalopathy syndrome (PRES) or vascular edema, wherein the method comprises the steps of;
(a) administering a first dosage to the patient;
(b) monitoring the patient and detecting the presence of PRES or vascular edema at a first time point;
(c) optionally administering a second dosage to the patient after the monitoring in step (b) detects presence of PRES or vascular edema;
(d) monitoring the patient and detecting the absence of PRES or vascular edema at a second time point; and
(e) administering another dosage to the patient after the monitoring in step (d) indicates absence of PRES or vascular edema,wherein the dosages in (a) and (e) are higher than the dosage in (c) if a dosage is administered in (c).
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Abstract
The invention provides preferred dosage ranges, maximum concentrations, average concentrations and monitoring regimes for use in treatment of Alzheimer'"'"'s disease using antibodies to Aβ. The invention also provides monitoring regimes that can assess changes in symptoms or signs of the patient following treatment.
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Citations
36 Claims
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1. A method of therapeutically treating Alzheimer'"'"'s disease, comprising administering by intravenous infusion to a human patient suffering from the disease a dosage of an antibody that specifically binds to an N-terminal fragment of beta-amyloid peptide (Aβ
- ) with a binding affinity of at least 107 M−
1, and monitoring the patient for posterior reversible encephalopathy syndrome (PRES) or vascular edema, wherein the method comprises the steps of;(a) administering a first dosage to the patient; (b) monitoring the patient and detecting the presence of PRES or vascular edema at a first time point; (c) optionally administering a second dosage to the patient after the monitoring in step (b) detects presence of PRES or vascular edema; (d) monitoring the patient and detecting the absence of PRES or vascular edema at a second time point; and (e) administering another dosage to the patient after the monitoring in step (d) indicates absence of PRES or vascular edema, wherein the dosages in (a) and (e) are higher than the dosage in (c) if a dosage is administered in (c). - View Dependent Claims (3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36)
- ) with a binding affinity of at least 107 M−
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2. A method of therapeutically treating Alzheimer'"'"'s disease, comprising administering by intravenous infusion to a human patient suffering from the disease a dosage of an antibody within a range of about 0.5 mg/kg to less than 5 mg/kg, wherein the antibody specifically binds to an N-terminal fragment of beta-amyloid peptide (Aβ
- ) with a binding affinity of at least 107 M−
1, and monitoring the patient for posterior reversible encephalopathy syndrome (PRES) or vascular edema, wherein the method comprises the steps of;(a) administering a first dosage to the patient; (b) monitoring the patient and detecting the presence of PRES or vascular edema at a first time point; (c) optionally administering a second dosage to the patient after the monitoring in step (b) detects presence of PRES or vascular edema; (d) monitoring the patient and detecting the absence of PRES or vascular edema at a second time point; and (e) administering another dosage to the patient after the monitoring in step (d) indicates absence of PRES or vascular edema, wherein the dosages in (a) and (e) are higher than the dosage in (c) if a dosage is administered in (c).
- ) with a binding affinity of at least 107 M−
Specification